A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued

NCT00633672 | Completed Phase 3

• 1 other identifier: SH-NEN-0006
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.

Conditions

NSAID Associated Gastric Ulcers

Keywords

NSAID; Nexium; esomeprazole; Gastric Ulcers

Outcome Measures

Primary Outcomes (1)

• To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers.

Secondary Outcomes (2)

• Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.

  Assessments at week 0, week 4 and week 8

• Safety and tolerability of the treatments for 8 weeks of treatment.

  Assessments at week 0, week 4 and week 8

Study Arms (3)

1

EXPERIMENTAL

20mg Oral tablet daily

Drug: Esomeprazole

2

EXPERIMENTAL

40mg oral tablet daily

Drug: Esomeprazole

3

ACTIVE COMPARATOR

150mg oral twice daily

Drug: Ranitidine

Interventions

Ranitidine DRUG

150mg oral twice daily

Also known as: Zantac

3

Esomeprazole DRUG

20mg Oral tablet once daily

Also known as: Nexium

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.

You may not qualify if:

• History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
• History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
• Other conditions and criteria, as specified in the protocol.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Stomach Ulcer

Interventions

Esomeprazole; Ranitidine

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Furans

Study Officials

• Paula Fernstrom

  Nexium Global Product Director, AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 12, 2008
• Study Start: February 1, 2001
• Primary Completion: October 1, 2003
• Study Completion: October 1, 2003
• Last Updated: January 25, 2011

Record last verified: 2011-01